Phacoemulsification surgical multi-use pack usage tracker system

ABSTRACT

A surgical cassette/pack usage tracker for tracking a number of uses for a cassette/pack to prohibit uses from exceeding a maximum amount. A usage tracker system engages with or scans a portion of the cassette/pack to determine the number of uses. In illustrative embodiments, an implement interacts with a film in the cassette after each use and determines remaining uses for the cassette/pack. In other embodiments, an implement interacts with a rotatable wheel that rotates with each use, the implement configured to permit the tracker to identify the number uses and determine remaining uses for the cassette/pack. When a maximum usage amount is reached, the tracker system may issue a warning, eject or reject the cassette/pack and/or disable the surgical device from further use.

BACKGROUND OF THE INVENTION

Field of Technology

The present invention relates generally to sensing usage of reusablecassettes/packs for surgical devices to determine if cassette/pack usagehas reached a maximum number.

Description of the Background

The optical elements of the eye include both a cornea (at the front ofthe eye) and a lens within the eye. The lens and cornea work together tofocus light onto the retina at the back of the eye. The lens alsochanges in shape, adjusting the focus of the eye to vary between viewingnear objects and far objects. The lens is found just behind the pupiland within a capsular bag, the capsular bag being a thin, relativelydelicate structure which separates the eye into anterior and posteriorchambers.

With age, clouding of the lens or cataracts is fairly common. Cataractsmay form in the hard central nucleus of the lens, in the softerperipheral cortical portion of the lens, or at the back of the lens nearthe capsular bag. Cataracts can be treated by the replacement of thecloudy lens with an artificial lens. Phacoemulsification systems oftenuse ultrasound energy to fragment the lens and aspirate the lensmaterial from within the capsular bag. This may allow the capsular bagto be used for positioning of the artificial lens, and maintains theseparation between the anterior portion of the eye and the vitreoushumor in the posterior chamber of the eye.

During cataract surgery and other therapies of the eye, accurate controlover the volume of fluid within the eye is highly beneficial. Forexample, while ultrasound energy breaks up the lens and allows it to bedrawn into a treatment probe with an aspiration flow, a correspondingirrigation flow may be introduced into the eye so that the total volumeof fluid in the eye does not change excessively. If the total volume offluid in the eye is allowed to get too low at any time during theprocedure, the eye may collapse and cause significant tissue damage.Similarly, excessive pressure within the eye may strain and injuretissues of the eye.

While a variety of specific fluid transport mechanisms have been used inphacoemulsification and other treatment systems for the eyes, aspirationflow systems can generally be classified in two categories: 1)volumetric-based aspiration flow systems using positive displacementpumps (e.g. peristaltic); and 2) vacuum-based aspiration systems using avacuum source, typically applied to the aspiration flow through anair-liquid interface within a reservoir (e.g. Venturi). Both systems maybe incorporated into one treatment system and/or cassette. Cassette(“pack”) systems may be used to couple peristaltic pump drive rotorsand/or vacuum systems of the surgical consoles to an eye treatmenthandpiece, with the flow network conduit of the cassette beingdisposable to avoid cross-contamination between different patients.

The disposable cassettes provide protection for each patient by avoidingcross-contamination between different patients. The disposable cassettesmay be single-use, where the cassette is disposed after one use, ormulti-use, where cassettes are reused after proper sterilization (e.g.,autoclaving). In the case of multi-use phacoemulsification (“phaco”)surgical packs, there is a maximum number of times a multi-use pack canor should be reused, as the pack quality deteriorates after certainamounts of usage and autoclave. Systems incorporating barcodes, such asone described in U.S. Pat. No. 6,036,458 to Cole et al., titled“Automated Phaco Pack Bar Code Reader Identification” issued Mar. 14,2000, which is incorporated by reference herein, have been proposed totrack usage and disposal of cartridges. However, such systems are noteffective in accurately and consistently tracking usage for disposalpurposes. Such systems are also not effective in accurately andconsistently tracking a pack used on more than one system or machine. Amechanism to track how many times the cassette has been used is neededto ensure that it will not be used more than the recommended maximumnumber of times.

SUMMARY

Accordingly, in an exemplary embodiment, a reusable cassette sensingapparatus, configured to be part of a surgical device, is disclosed. Theapparatus may comprise a film configured to indicate a maximum number ofuses of the surgical device, and a tracking system comprising animplement, at least one sensor and a processor, wherein the implement isconfigured to engage with the film, and wherein the at least one sensoris configured to sense the maximum number of uses from the film, and,prior to use of the surgical device, the processor is configured todetermine if the maximum number of uses has been reached based at leaston a number of engagements of the implement with the film.

Under another exemplary embodiment, a method is disclosed for trackingusage of a reusable cassette, configured to be part of a surgicaldevice, the method comprising the steps of sensing, prior to use of thesurgical device, a maximum number of uses from a film configured toindicate a maximum number of uses of the reusable cassette; providedthat the maximum number of uses has not been reached, activating animplement to engage with the film; and based at least in part on theimplement's engagement with the film, determining a remaining number ofusage for the reusable cassette. Alternatively, the film may be pre-cutwith a number of apertures or holes, and wherein a single solid portionrepresents the last use, thereby determining that the cassette has beencompletely used when the implement engages with the solid portioninstead of an aperture or hole.

Under another exemplary embodiment, a method is disclosed for trackingusage of the reusable cassette, configured to be part of the reusablecassette, where a “pinwheel” or wheel is divided into segmentsrepresenting the maximum number of uses, and where an open hole orclear/light colored segment indicates available usage but a closed holeor dark/black color segment represents that the cassette/pack hasreached its maximum use amount.

Under another exemplary embodiment, a method is disclosed for trackingusage of a reusable cassette, configured to be part of a surgicaldevice, the method comprising the steps of advancing a pinwheel or wheelto a next segment when a cassette/pack is inserted into the device(based on idea of advancing film in camera), sensing the current usagecount of the cassette through emission of light aimed at an open hole orclear/light segment of the pinwheel, and continuing to advance thepinwheel until the system senses a closed hole or dark/black segmentindicating the maximum number of uses has been reached, the system usingsoftware to determine if the multi-use pack has reached its maximumusage.

Under another exemplary embodiment, a method is disclosed for trackingusage of the reusable cassette, configured to be part of the reusablecassette, where the tracking system includes a “rotating wheel/gear.”The wheel/gear is divided into segments representing the maximum numberof uses, where an open hole or clear/light colored segments indicateavailable usage, but a closed hole or dark/black color segmentrepresents that the pack has reached maximum uses. When the methodinvolves an open hole verses a closed hole, a probe or processor sensingresistance may be utilized to determine the segment. When the methodinvolves a clear/light colored segment verse a dark/black coloredsegment, a sensor and/or light-emitting mechanism may be used.

Under another exemplary embodiment, a method is disclosed for trackingusage of a reusable cassette, configured to be part of a surgicaldevice, the method comprising the steps of advancing a rotatingwheel/gear through an axel rod residing in the instrument. The rod, wheninserted, will turn and advance the wheel to the next segment when apack is inserted. Alternatively, two or more gears may be used (e.g. onein the pack and one in the console or surgical device) to connect andturn or advance the wheel. The method further comprises sensing, througha light source such as an LED light, the current segment or spacing ofthe wheel. For example, the light may be aimed at the open hole orclear/light segments of the wheel when the cassette has not reached itsmaximum usage. The light may be aimed at the closed hole or dark/blacksegments of the wheel when the cassette has reached its maximum usage.The method includes software to determine if the multi-use pack hasreached its maximum usage.

DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the invention, and are incorporated in and constitute apart of this specification. The drawings illustrate disclosedembodiments and/or aspects and, together with the description, serve toexplain the principles of the invention, the scope of which isdetermined by the claims.

FIG. 1 is a schematic illustrating an embodiment of an eye treatmentsystem in which a cassette is coupled to an eye treatment probe, thecassette being further coupled with an eye treatment console;

FIG. 2 is a functional block diagram of an exemplary cassette systemunder one embodiment, the cassette system being connected to ahandpiece, a vacuum pump arrangement and a collector;

FIG. 2A is another functional block diagram of an exemplary cassettesystem under one embodiment, the cassette system being connected to ahandpiece, a vacuum pump arrangement and a collector;

FIG. 2B is a schematic illustrating detailed elements of a cassettesystem and eye treatment console as shown in FIG. 1;

FIG. 3 illustrates an exemplary cassette tracking system for determiningcassette usage under one embodiment, the cassette tracking systemincluding a film usage system and film;

FIG. 3A illustrates an exemplary film for tracking cassette usage underthe embodiment of FIG. 3, wherein a punch system for tracking the numberof uses of the cassette;

FIG. 3B illustrates another exemplary film for tracking cassette usageunder the embodiment of FIG. 3, wherein conductive threads between avoltage source and ground may be selectively cut to track the number ofuses of the cassette;

FIG. 4 illustrates an exemplary process for determining and restrictingcassette usage under one embodiment;

FIG. 5A illustrates a side perspective view of another exemplarycassette tracking system for determining cassette usage, the cassettetracking system including a rotatable wheel and sensing mechanism totrack the rotation of the wheel;

FIG. 5B illustrates a front perspective view of the cassette trackingsystem of FIG. 5A;

FIG. 6 illustrates a front perspective view of another exemplarycassette tracking system for determining cassette usage, the cassettetracking system including a rotatable wheel with variations and asensing mechanism to track rotation of the wheel;

FIG. 7 illustrates another exemplary cassette tracking system fordetermining cassette usage, the cassette tracking system including arotating track with a latch that mates with a rotatable wheel to rotatethe wheel to a predetermined position, the wheel further including aprotrusion that prevents the latch from further rotation at thepredetermined position;

FIG. 7A shows another view of the cassette tracking system of FIG. 7,where the protrusion from the wheel meets the latch of the rotatingtrack;

FIG. 7B illustrates another exemplary cassette tracking system fordetermining cassette usage, the cassette tracking system including arotating track with a latch that contacts a resilient protrusion in theconsole for tracking and/or preventing cassette usage beyond apredetermined limit;

FIG. 7C illustrates another exemplary cassette tracking system fordetermining cassette usage, the cassette tracking system including arotating track with a resilient latch that contacts a fixed protrusionin the console for tracking and/or preventing cassette usage beyond apredetermined limit;

FIG. 7D illustrates another exemplary cassette tracking system fordetermining cassette usage, the cassette tracking system including arotating disc with insertion pockets configured to mate with animplement for tracking and/or preventing cassette usage beyond apredetermined limit;

FIG. 8 is a functional block diagram of an exemplary cassette systemunder another embodiment, the cassette system being connected to aconsole, the cassette system including an RFID chip that is readable bythe console; and

FIG. 9 shows another illustrative embodiment of a wheel suitable for usein a cassette tracking system, where the wheel includes an open trackconfigured to receive a protrusion or structure, and wherein the trackhas a first starting point and a second ending point that preventsfurther advancement by the protrusion.

DETAILED DESCRIPTION OF THE INVENTION

It is to be understood that the figures and descriptions of the presentinvention have been simplified to illustrate elements that are relevantfor a clear understanding of the present invention, while eliminating,for the purpose of clarity, many other elements found in typicalsurgical, and particularly optical surgical, apparatuses, systems, andmethods. Those of ordinary skill in the art may recognize that otherelements and/or steps are desirable and/or required in implementing thepresent invention. However, because such elements and steps are wellknown in the art, and because they do not facilitate a betterunderstanding of the present invention, a discussion of such elementsand steps is not provided herein. The disclosure herein is directed toall such variations and modifications to the disclosed elements andmethods known to those skilled in the art.

Referring now to FIG. 1, a system 10 for treating an eye E of a patientP generally includes an eye treatment probe handpiece 110 coupled with aconsole 115 by a cassette 250. Handpiece 110 generally includes a handlefor manually manipulating and supporting an insertable probe tip (notshown). The probe tip has a distal end which is insertable into the eye,with one or more lumens (not shown) in the probe tip allowing irrigationfluid to flow from console 115 and/or cassette 250 into the eye Ethrough an irrigation port connected to the lumen. The distal end of theprobe tip may further include an aspiration port coupled to anotherlumen through which fluid may also be withdrawn or aspirated by way ofan aspiration source. In an exemplary embodiment, the console 115 andcassette 250 may generally include a vacuum aspiration source, apositive displacement aspiration pump, or both to help withdraw andcontrol a flow of surgical fluids into and out of eye E. As the surgicalfluids may include biological materials that should not be transferredbetween patients, cassette 250 will often comprise a sterilizable (oralternatively, disposable) structure, with the surgical fluids beingtransmitted through flexible conduits 120 of cassette 250 that avoiddirect contact in between those fluids and the components of console115.

When a distal end of the probe tip of handpiece 110 is inserted into aneye E, for example, for removal of a lens of a patient P with cataracts,an electrical conductor and/or pneumatic line (not shown) may supplyenergy from console 115 to an ultrasound transmitter of handpiece 110, acutter mechanism, or the like. Alternatively, handpiece 110 may beconfigured as an irrigation/aspiration (I/A) and/or vitrectomyhandpiece. Also, the ultrasonic transmitter may be replaced by othermeans for emulsifying a lens, such as a high energy laser beam. Theultrasound energy from handpiece 110 helps to fragment the tissue of thelens, which can then be drawn into the aspiration port of the tip byaspiration flow. In exemplary embodiments, it is preferable to maintaina certain amount of fluid within the eye E at all times during asurgical procedure. Accordingly, in order to balance the volume of fluidand material removed by the aspiration flow, an irrigation flow throughhandpiece 110 (or a separate probe structure) and through the irrigationport may also be provided, with both the aspiration and irrigation flowsbeing controlled by console 115.

To avoid cross-contamination between patients without incurringexcessive expenditures for each procedure, cassette 250 and its flexibleconduits 120 may be disposable. In other embodiments, the flexibleconduit or tubing 120 may be disposable, while the cassette body 250and/or other structures of the cassette 250 are sterilizable and/orreusable. Cassette 250 may be configured to interface with reusablecomponents of console 115, including, but not limited to, peristalticpump rollers, a Venturi or other vacuum source, a controller 125, and/orthe like, as discussed below.

As illustrated in FIG. 1, console 115 may include a controller 125.Controller 125 may include an embedded microcontroller and/or many ofthe components common to a personal computer, such as a processor, databus, a memory, input and/or output devices (including a user interface130 (e.g. touch screen, graphical user interface (GUI), etc.), and thelike. Controller 125 may often include both hardware and software, withthe software typically comprising machine readable code or programminginstructions for implementing one, some, or all of the methods describedherein. The code may be embodied by a tangible media such as a memory, amagnetic recording media, an optical recording media, or the like.Controller 125 may have (or be coupled with) a recording media reader(not shown), or the code may be transmitted to controller 125 by anetwork connection such as an internet, an intranet, an Ethernet™, awireless network, or the like. Along with programming code, controller125 may include stored data for implementing the methods describedherein, and may generate and/or store data that records parameterscorresponding to the treatment of one or more patients. Many componentsof console 115 may be found in or modified from known commercialphacoemulsification systems from Abbott Medical Optics Inc. of SantaAna, and other suppliers.

Referring to FIG. 2, an exemplary cassette system 200 showing some ofthe components and interfaces that may be employed in aphacoemulsification system. In illustrative embodiments, the cassettesystem 200 includes, for example, the cassette 250, which furtherincludes, for example, a vacuum sensor 201, a flow selector valve 202,one or more pumps 203/205, and a reservoir 204. Handpiece 110 isconnected to (or coupled with) the input side of fluid vacuum sensor201, typically by conduits 120. In illustrative embodiments, theconduits 120 may comprise fluid pathways such as a fluid pathway 220.The output side of fluid vacuum sensor 201 is connected to flow selectorvalve 202 within cassette 250 via a fluid pathway 221. The presentdesign may configure flow selector valve 202 to interface betweenhandpiece 110, a balanced saline solution (BSS) fluid bottle 112, afirst pump 203 (which is shown as a peristaltic pump but may be anothertype of pump), and reservoir 204. In various embodiments, flow selectorvalve 202 may connect with fluid bottle 112 via a flow pathway (between202 and 112), flow selector valve 202 may connect with pump 203 via aflow pathway 223, and flow selector valve 202 may connect with reservoir204 via a flow pathway 226. In this configuration, the system mayoperate flow selector valve 202 to connect handpiece 110 with BSS fluidbottle 112, reservoir 204 or with pump 203 based on signals receivedfrom console 115 resulting from the surgeon's input to user interface130 or any other system input device.

In illustrative embodiments, the flow selector valve 202 illustrated inFIG. 2 provides a single input port ‘0’, and may further connect port‘0’ to one of three available ports numbered ‘1’, ‘2’, and ‘3’. Thepresent design is not limited to one flow selector valve, and may berealized using two flow selector valves each having at least two outputports, possibly connected together to provide the functionalitydescribed herein. For example, a pair of two output port valves may beconfigured in a daisy chain arrangement, where the output port of afirst valve is directly connected to the input port of a second valve.Console 115 may operate both valves together to provide three differentflow configurations. For example, using two valves, a first valve mayinclude at least a first output port and a second outlet port, with thefirst output port being the supply for a second valve. The second valvemay connect to one of two outlet ports to provide two separate paths.When the first valve connects its input port to its second output portrather than the first output port, a third path is provided. Other meansof providing multiple outlet ports are well known in the industry.Further, it is envisioned that a cassette system 200 may require morethan three outlet paths and that a variety of flow selector valves or aseries of flow selectors valves that can create the desired number ofoutlet paths are well known in the industry.

It is also envisioned that flow selector valve 202 may be or compriseone or more pinch valves (not shown). As an illustrative example, theone or more pinch valves may be located along fluid pathway 221 and/or223, or any other fluid pathway as discussed herein. Further, there maybe one or more fluid pathways coupled with handpiece 110 and extendingto various components of cassette 250. In another embodiment, fluidpathway 220 from handpiece 110 is a single fluid pathway that coupleswith fluid vacuum sensor 201. In certain embodiments, there are multiplepathways within cassette system 200, including a first fluid pathwayfrom fluid vacuum sensor 201 to collector 206 via pump 203 and/or asecond fluid pathway from vacuum sensor 201 to reservoir 204. From fluidvacuum sensor 201, the single fluid pathway 220 may divide into twofluid pathways, one to collector 206 via pump 203 and one to reservoir204. Further, one or more pinch valves and/or flow selector valve 202may be located along the fluid pathway between fluid vacuum sensor 201and collector 206 and/or between fluid vacuum sensor 201 and reservoir204.

Thus while a single flow selector valve 202 is illustrated in FIG. 2, itis to be understood that this illustration represents a flow selectorvalve arrangement, including one or more flow selector valves performingthe functionality described herein, and is not limited to a singledevice or a single flow selector valve.

In illustrative embodiments, the fluid vacuum sensor 201 may include,for example, a strain gauge or other suitable component, thatcommunicates or provides signal information to console 115 to providethe amount of vacuum sensed in the fluid pathway 220 or, moreparticularly, in one or more lumens within the handpiece 110. Console115 may determine the actual amount of vacuum present based on thecommunicated information.

Fluid vacuum sensor 201 monitors flow into and out of the handpiece 110,and can be used to determine when flow should be reversed, such asencountering a certain pressure level (e.g. in the presence of anocclusion). Based on values or information obtained from the fluidvacuum sensor 201, the console 115 or another part of the system maycontrol selector valve 202 and the pump(s) 203/205, as illustrated. Itis to be understood that while components presented in FIG. 2 and otherdrawings of the present application are not shown connected to othersystem components, such as console 115, they are in fact connected forthe purpose of monitoring and controlling of the components illustrated.

As discussed previously, it may be desirable to maintain or control theamount or pressure of fluid flowing into or out of the eye E during asurgical procedure. With respect to fluid vacuum sensor 201, emergencyconditions, such as a dramatic drop or rise in pressure as determined byfluid vacuum sensor 201, may result in a type of fail-safe operationbeing employed. The present design employs fluid vacuum sensor 201 tomonitor the flow conditions and provide signals representing flowconditions to the system, such as via console 115, for the purpose ofcontrolling components shown, including but not limited to flow selectorvalve 202 and the pumps 203/205 shown. The fluid pathways or flowsegments of surgical cassette system 200 may include fluid connections,for example flexible tubing, between each component represented withsolid lines in FIG. 2.

In illustrative embodiments, cassette system 200 is coupled to a vacuumpump arrangement 207. In other embodiments, vacuum pump arrangement 207may be integral with cassette system 200. Vacuum pump arrangement 207 istypically coupled with console 115, and may be connected with reservoir204 via a fluid pathway or flow segment 230. In the configuration shownin FIG. 2, vacuum pump arrangement 207 includes a pump 208, such as aventuri pump, and an optional pressure regulator 209 (and valve (notshown)), but other configurations for the pump arrangement 207 arepossible. In this arrangement, vacuum pump arrangement 207 may operateto remove air from the top of reservoir 204 and deliver the air toatmosphere (not shown). Removal of air from reservoir 204 in this mannermay reduce the pressure within the reservoir 204, causing an air-fluidboundary 213 in reservoir to move upward. This reduction in pressurewill cause a reduction in the pressure in the fluid pathway 226 coupledto the reservoir 204. In illustrative embodiments, the pressure in fluidpathway 226 may be reduced to a level less than the pressure within eye114. A lower pressure in fluid pathway 226 (from a lower pressure inreservoir 204) connected to flow selector valve 202 may cause fluid tomove through the upstream pathways of flow selector valve 202, includingpathway 221 and 220, from the eye 114. Accordingly, the lower pressurein reservoir 204 may cause fluid to move from the eye 114 via fluidpathway 220, thereby providing aspiration. The vacuum pump arrangement207 and reservoir 204 can be used to control fluid flow into and out ofreservoir 204.

Conversely, the optional pressure regulator 209 may operate to add airto the top of reservoir 204 which in turn increases pressure and mayforce the air-fluid boundary 213 to move downward. Adding air intoreservoir 204 in this manner may increase the air pressure within thereservoir 204, which increases the pressure in the attached fluidaspiration line 226. In illustrative embodiments, the pressure in thefluid aspiration line 226 may be increased to a level greater than thepressure within eye 114. A higher reservoir pressure connected throughflow selector valve 202 may cause fluid to move toward eye 114, therebyproviding venting or reflux. Other means for providing venting or refluxare well known in the art.

The present design may involve peristaltic operation—aspirating fluidfrom the eye 114 to collector 206 as illustrated in FIG. 2—or ventingoperation—venting fluid to the eye 114 to reduce the amount of pressurein an aspiration line (where such venting is shown, for example, fromBSS bottle 112 in FIG. 2). Peristaltic pumping is generally understoodto those skilled in the art, and many current machines employperistaltic and/or venturi pumps as the vacuum or pressure sources.Generally, a peristaltic pump has fluid flowing through a flexible tubeand a circular rotor with a number of rollers attached to the peripheryof the circular rotor. As the rotor turns, fluid is forced through thetube. Venturi pumping, or aspiration or aspirator pumping, produces thevacuum using the Venturi effect by providing fluid through a narrowingtube. Because of the narrowing of the tube, the speed at which the fluidtravels through the tube increases and the fluid pressure decreases (the“Venturi effect”). As may be appreciated, operating pumps in onedirection or another can change the pressure and the operation of theassociated device, such as the operation of the cassette in the presentdesign.

Referring now to FIG. 2A, another system is illustrated. FIG. 2Agenerally highlights the surgical aspiration and irrigation fluidcontrol elements included within the cassette 250 and console 115. Theirrigation components are often relatively straightforward and known inthe industry. A BSS fluid bottle 112 or the like connected to console115 optionally provides irrigation fluid pressure control by relying atleast in part on a gravity pressure head that varies with a height ofBSS fluid bottle 112. An irrigation on/off pinch valve 48 may generallyinclude a short segment of a flexible conduit lumen (e.g. 113 of FIG. 2)of or coupled to cassette 250, which can be engaged and actuated by anactuator (not shown) of console 115. A surface of cassette body 78 maybe disposed opposite the actuator to facilitate closure of the conduitlumen. Alternative irrigation flow systems may include positivedisplacement pumps, alternative fluid pressurization drive systems,fluid pressure or flow modulating valves, as discussed above, and/or thelike.

FIG. 2A further illustrates the aspiration components. Aspiration flowpath 52 couples an aspiration port (not shown) in the tip of handpiece110 with pump 203 and/or a reservoir 204. Fluid aspirated throughhandpiece 110 may be contained in reservoir 204 regardless of whetherthe aspiration flow is induced by pump 203 or vacuum pump arrangement207. For instance, when a selector control valve 58 positioned betweenvacuum fluid sensor 201 and reservoir 204 is closed and pump 203 is inoperation, pumping of the aspiration flow may generally be directed bythe pump 203, independent of the pressure in the reservoir 204. In suchcase, the aspiration flow may flow through conduit 54 a. Conversely, ifpump 203 is a peristaltic pump and is off, flow through the pump 203 maybe halted by pinching of the elastomeric tubing arc of the peristalticpump by one or more of the individual rollers of the peristaltic pumprotor (similar to the rollers of 60 b in pump 205). Hence, anyaspiration fluid drawn into the aspiration network (fluid pathways) whenpump 203 is off will typically involve the opening of selector controlvalve 58 so that the aspiration port of the probe or handpiece 110 is influid communication with reservoir 204. Alternatively, communicationwith vacuum pump arrangement 207 may be accomplished by disengaging theperistaltic probe drive from the elastomeric tubing. The pressure withinreservoir 204 may be maintained at a controlled vacuum level, often at afixed vacuum level, by vacuum pump arrangement 207. Vacuum pumparrangement 207 may comprise a vacuum (e.g. Venturi) pump, a rotary vanepump, a vacuum source, pressure regulator, or the like. Aspiration fluidthat drains into reservoir 204 may be removed by pump 205 and directedto collector 206 via a fluid pathway 60 a. Vacuum pressure at thesurgical handpiece 110 may be maintained within a desired range throughcontrol of the fluid level in reservoir 204.

Referring now to FIG. 2B, an interface 70 between cassette 250 andconsole 115 is schematically illustrated. Many of the fluid networkstructures described above regarding FIGS. 2 and 2A include or make useof corresponding elements of cassette 250 and the console 115. Forexample, with respect to FIG. 2A, fluid vacuum sensor 201 may beincluded in a pressure sensing system which includes a pressure sensor201 a in cassette 250 having a pressure chamber (not shown) and asurface (not shown) that moves in response to variations in the pressurein the chamber. Axial movement of the pressure sensor surface may bedetermined using a pressure receiver 201 b which may be incorporatedinto console 115. In the exemplary embodiments, direction of movement ofthe pressure sensor surface may be aligned with a mounting axis 76 ofcassette 250, representing a direction of movement of cassette 250during mounting of cassette 250 to console 115.

Similarly, other components of cassette 250 and console 115 may bepredetermined to engage with each other about interface 70. Selectorvalve 58 may make use of a resilient valve conduit 58 a in cassette 250that is engaged by an actuator 58 b of console 115. As described above,pump 203 may include a conduit 54 a of cassette 250 engaged by aperistaltic rotor 54 b of console 115, with the interface 70 effectingengagement between the conduit 54 a and the peristaltic rotor 54 b. Avacuum coupler 72 a of cassette 250 may engage a vacuum coupler 72 b ofconsole 115 so as to allow vacuum pump arrangement 207 to apply a vacuumto reservoir 204 (See FIG. 2A). Reservoir 204 may be coupled with afluid detector 74 b of console 115 using a mechanical, electrical, orlight fluid presence detector system so as to allow controller 125 ofconsole 115 to determine when it is appropriate to energize pump 205.Rather than simply detecting the presence of fluid, alternativeembodiments might employ a more complex fluid level sensing system whichdetermines a quantity or volume of fluid in the tank for purposes ofselectively energizing pump 205. Pump 205 includes a conduit 60 a ofcassette 250 and a peristaltic rotor 60 b of console 115. Irrigationvalve 48 may include a resilient valve conduit 48 a of cassette 250 anda valve actuator 48 b of console 115. Other components—electrical,mechanical, or otherwise—may be predesigned to engage with each otherfrom the cassette 250 and the console 115.

Engagement and alignment between cassette 250 and the interfacingstructures of console 115 may be achieved through a variety ofmechanisms, some of which are described in U.S. Pat. No. 8,491,528 toMuri et al., titled “Critical Alignment of Fluidics Cassettes” issuedJul. 23, 2013 and U.S. Pat. Pub. No. 2010/0249,693 to Jeremy T. Links,titled “Cassette Capture Mechanism,” filed Mar. 31, 2009, each of whichare incorporated by reference in their entirety herein. A cassette 250may generally have a height and a width which generally are greater thana thickness of cassette 250 along a mounting axis, allowing theinterfacing fluid pathway network elements of cassette 250 andcorresponding components of console 115 to be distributed in a roughlyplanner configuration. In addition to the individual interfaces,cassette 250 may generally include a cassette body 78 with positioningsurfaces 80 that engage corresponding with cassette receptacle surfaces82 of console 115. Cassette receptacle surfaces 82 define a cassettereceptacle 100 that receives and positions cassette 250. In oneexemplary embodiment, cassette 250 is manually supported and advancedalong mounting axis 76 until positioning surfaces 80 engages anddeflects an alignment switch 84 of console 115. One or more alignmentswitches may be used; preferably two alignment switches are employedwith a cassette receptacle on console 115. The alignment switch may be apin/flag, optical, magnetic, or any other detection mechanism known inthe art.

In various embodiments, a cassette may be designated for a predeterminedor set number of uses before it should be disposed of and replaced witha new cassette. In the present disclosure, the number of usages of aparticular cassette 250 may be determined or tracked in order to ensurea specific cassette 250 is not utilized past its predetermined usageamount. Such tracking is beneficial to avoid overuse of a cassette thatcould cause undesired effects, such as unintentional contamination frompreviously aspirated materials, during a surgical procedure. In variousembodiments, the number of predetermined uses will be dependent on thesize and functionality of the cassette 250. For instance, a particularcassette may require disposal after a maximum of 15-30 uses. A varietyof cassettes with varying maximum use requirements are known in theindustry.

Turning to FIG. 3, an exemplary embodiment is provided where a usagetracking system 300 interacts with a film 301 for tracking cassetteusage. In one embodiment, film tracking system 300 and film 301 areconfigured to be inside a cassette 250 to avoid potential contaminationand/or damage. In another embodiment, tracking system 300 and film 301may be configured separately from the cassette 250. For example, system300 and film 301 may be encased in a separate housing (not shown) thatis cooperatively attachable to a cassette 250. In another embodiment,film tracking system may be configured to be inside console 250 and film301 may be configured to be inside or coupled with cassette 250. Asnoted previously, the usage tracking system 300 may be configured topermit adequate tracking of the number of uses of a cassette even whenthe cassette has been removed from one system and incorporated intoanother system. It should be understood by those skilled in the art thata specific cassette/pack incorporating usage tracking system 300 maycomprise greater or fewer internal components that those listed herein.

As can be seen in FIG. 3, system 300 may comprise an implement or probe302 suitable for physically interacting with film 301. In oneembodiment, implement 302 may comprise a punch or similar structure thatpenetrates through the surface of film 301. In another embodiment,implement 302 may comprise a blade for cutting through a portion of film301. In a still further embodiment, implement 302 may comprise a markingimplement that ejects ink or electrically conductive ink onto thesurface of film 301. In a still further embodiment, film 301 maycomprise photoreactive material that discolors or otherwise reacts tolight illumination, and the implement 302 may include a light source orother light-emitting feature that shines onto the photoreactivematerial. It should be understood by those skilled in the art that othertypes of implements are envisioned through the present disclosure.

Implement 302 is operatively coupled to an activator 303, which causesimplement 302 to punch/cut/mark/effect film 301. Activator 303 mayfurther comprise a mechanism and circuitry to provide a linear forcealong a plane covering the area of film 301 (shown as arrows in FIG. 3)to provide punching, cutting, marking, etc of film 301. In the case of amarker implement, activator 303 may be integrated as part of implement302 and provide the mechanism and activation for implement 302 toprovide ink onto the surface of film 301. In the case of alight-emitting implement, activator 303 may further provide themechanism and circuitry for emitting light onto the surface of film 301.

In various embodiments, film 301 may be partitioned into predeterminedspaces (e.g. boxes in FIG. 3A). The predetermined spaces may bedetermined to represent the maximum number of uses of the cassette 250.Implement 302 may be configured to punch/cut/mark/effect a single spaceon film 301 with every use of the cassette 250. Activator 303 may becoupled to a sensor 304 which may be configured to optically and/orelectrically sense remaining, unmarked or un-illuminated spaces left onfilm 301, thereby indicating the number of remaining uses left for aparticular cassette 250. Accordingly, the number of remaining uses for acassette 250 may be tracked and determined by the system in order toensure the cassette 250 does not exceed its maximum number of uses.

Sensor 304 may further comprise a secondary sensor capable of detectingfilm configuration data provided by a film code 322 on film 301,explained further in detail below in connection with FIG. 3A. Inillustrative embodiments, sensor 304 is operatively coupled to aprocessor 305 and a memory 321, which may provide operationalinstructions for operating activator 303 or implement 302. System 300may further comprise a communication system 320, which may allow system300 to send/receive data, preferably via a wireless communication datalink. Exemplary communication systems include, but are not limited to,Bluetooth, WiFi, cellular, RFID, and near field communication (NFC).Under one exemplary embodiment, operational parameters for sensor 304and/or activator 303 may be communicated to processor 305 viacommunication system 320. Similarly, data obtained from sensor 304 orimplement 302 may be communicated externally as well.

As illustrated in FIG. 3, when a particular cassette is engaged and usedfor a first time, sensor 304 may scan and sense a maximum number ofallowable uses for the cassette from a film code 322 (shown in FIG. 3A)on film 301. Upon first use of the cassette, processor 305 may engageactivator 303 to cause implement 302 to punch film 301 (indicated bysolid arrow in FIG. 3). Prior to each subsequent use, sensor 304 mayscan and sense the remaining uses (indicated by remaining spaces on film301), and provided remaining uses are available, processor 305 mayengage activator to cause implement 302 to punch film 301 each timeanother use takes place (indicated by dotted arrows in FIG. 3). When nofurther uses are available, processor 305 may send a “disposal” signalto indicate no further uses are available. This signal may comprise awarning signal that may optically indicate (e.g. LED light) or audiblyindicate (e.g., via speakers) that the maximum number of uses have beenreached. The signal may also comprise a shut-down signal that disallowsfurther use of the device until another cassette is installed. Thesignal may also comprise an eject signal, which causes one or moreactuators to eject the cassette and not allow re-engagement of the samecassette. Other means for sending such a disposal signal are well knownin the industry.

Turning now to FIG. 3A, an exemplary embodiment is provided of a film301 configured to be used in the embodiment of FIG. 3. Here, film 301may be segmented into a plurality of rows 306 and columns 307 containingan area or space 308 wherein implement 302 may engage. Under oneexemplary embodiment, the segmentation of rows 306 and columns 307allows sensor 304 to scan the area of the film to determine what areaswere already punched/cut (309) and/or the spaces remaining that have notbeen punched/cut (adjacent arrow 308). Of course, as described above, asimilar configuration may be implemented for ink markings or lightemitting as well. It should also be appreciated by those skilled in theart that, while a grid configuration of spaces 308 has been disclosed,other physical configurations, such as a linear strip or single row 306of spaces 308, are envisioned as well.

Under one exemplary embodiment, a film identifier or code 322 may beused that provides information on the film 301 and the number of maximumuses available. In one embodiment, film identifier 322 comprises a barcode, QR code, or the like. In another embodiment, film identifier 322comprises an RFID tag, or similar communication protocol. Thus, whenfilm 301 is engaged with system 300, a scan from sensor 304 of filmidentifier 322 would indicate, for example, that film 301 is configuredto allow X number of uses. Such information would then be conveyed toprocessor 305. After each use, processor 305 could simply count downautomatically the remaining uses until a maximum is reached, andthereafter send the “disposal” signal as described above.

Turning to FIG. 3B, another exemplary embodiment of a usage trackingsystem 300 is provided where a film 301 comprises a plurality ofconductive threads 311 coupled between a voltage area 309 and ground310. The system of FIG. 3B may include similar components as discussedabove. In this example, implement 302 may be configured to cut eachthread 311 of film 301 after each use of the cassette. The voltage area309 or ground 310 may be electronically coupled to the sensor 304 suchthat the sensor 304 can determine the number of cut or full-lengththreads 311 on film 301. Accordingly, the remaining threads 311 on film301 would indicate the number of remaining uses left, thereby permittingthe processor 305 coupled to the sensor 304 to track uses of thecassette.

FIG. 4 illustrates an exemplary method of using the configurationillustrated in FIG. 3 and/or in other embodiments disclosed herein. Instep 401, system 300 scans film 301 to determine the number of usesallowed (usage limit). The scan may comprise an electrical/optical scanof the film 301 surface, or voltage readings in the voltage area 309 orground 310, by sensor 304, and/or information provided by identifier322. In step 402, use of a surgical device provides activation 402,wherein system 300 determines if a limit has been reached 403. If themaximum number of uses has been already reached, system 300 provides aneject/disable/warning/disposal signal 404 to warn or prevent furtherusage. If, in 403, remaining uses are available, activator 303 may causeimplement 302 to punch 405 (or otherwise mark or effect) film 301. Thecassette may thereafter be used during a surgical operation. Afterwards,the usage limit may be updated 406 to reflect the recent usages, and,upon subsequent uses, scan 401 may be repeated. The process may continuenumerous times until a limit in step 403 has been reached.

Turning to FIGS. 5A and 5B, another exemplary embodiment of a usagetracking system 300 is provided including a pinwheel or wheel 330 and areader 340. Although not shown in FIGS. 5A and 5B, the wheel 330 may becoupled to an activator 303 as described above such that the activator303 can control the wheel 330 based input from the sensor 304 and/orprocessor 305. In illustrative embodiments, the wheel 330 may be locatedin a cassette and is configured to advance or rotate a specific amountof degrees with every use of the cassette. In addition in an embodiment,the other components of the usage tracking system 300 may be located inthe console 115. As illustrated in FIG. 5B, a surface 332 of the wheel330 may be partitioned or divided in order to provide predeterminedspaces 308 that correspondence with the number of maximum uses of thecassette. As an example, this may be accomplished by dividing the wheel330 into pie-sized sections 334, or any other suitable shape. As thewheel 330 rotates, each section 334 a, 334 b, etc, include a light orwhite color segment 336, except the last section 334 x may include ablack or dark color segment 338. The reader 340 may be fixedlypositioned to read a different section 334 as the wheel 330 rotates. Inillustrative embodiments, the reader 340 may include optical sensors 342or provide a sensing mechanism through resistance in the console. As thewheel advances around for each use of the cassette, the sensors 342 willdetect the white or light colored segments 336 until the wheel 330rotates to place the black or dark colored segment 338 in line with thesensor 342. When the reader 340 reads the black or dark color segment338, then the cassette pack can no longer be used and the processor 205may send the “disposal” signal to the system.

Turning to FIG. 6, another exemplary embodiment of a usage trackingsystem 300 is provided including a wheel 330 and a pinion 350 isillustrated. As discussed above with regard to FIGS. 5A and 5B, thewheel 330 may be coupled to an activator 303 as described above suchthat the activator 303 can control the wheel 330 based on input from thesensor 304 and/or processor 305. In illustrative embodiments, the wheel330 may be located in a cassette and is configured to advance or rotatea specific amount of degrees with every use of the cassette. In additionin an embodiment, the other components of the usage tracking system 300may be located in the console 115. As illustrated in FIG. 6, the wheel330 may be partitioned or divided into substantially equal segments 336and 338 that correspond with the number of maximum uses of the cassette.The wheel 330 may include an edge 352 that surrounds and aligns with thesegments 336 and 338. Each segment 336 and 338 may include an outwardlyextending protrusion 354, as illustrated in FIG. 6.

The pinion 350 may be configured to abut against or be biased againstthe edge 352 of the wheel 330. As the wheel 330 advances or rotates dueto use of the cassette, the pinion 350 rides up and over the extendingprotrusion 354 of the segment 336 to sit or abut against the nextsegment 336. When the pinion 350 abuts against the last segment 338, thewheel 330 may be prevented from further rotation. Alternatively, thelast segment 338 may include black or dark coloring, and the pinion 350may include a reader (similar to 340) that can detect the color change,as discussed above. In such a way, the usage tracking system 300 mayoperate similar to a camera advancing mechanism where the pinwheel 330rotates clockwise/counter-clockwise with each advancement to catch thespokes or protrusions of the wheel. Similar sensing mechanisms asdiscussed in paragraph above.

In another embodiment, the usage tracking system 300 may be like film ina camera where it continues to turn until the film runs out, therebymaking it such that the wheel can no longer turn. When this occurs, themaximum number of uses for that cassette has been reached and thecassette can no longer be used.

Turning to FIG. 7, another exemplary embodiment of a usage trackingsystem 300 is provided. In this example, protrusion 390 is provided to aportion (e.g., underside) of wheel 330 of cassette 250, that may beinserted into console 365. Console 365 may be configured with a motor366 arranged to turn/rotate track 368, and may further include structure364 protruding on the console side. Motor 366 may be configured toturn/rotate track 368 freely, or may be configured to turn/rotate track368 in a controlled manner (e.g., a predetermined amount of rotation(s);rotating the track a predetermined amount for each rotation, etc.).After a full rotation, protrusion 390 will come into contact withstructure 364, which will impede further movement, indicating the packhas been used a maximum number of times.

When a new pack or cassette 250 is inserted, the pack may be configuredsuch that protrusion 390 is positioned in the same position each time,such as the position illustrated in the front view of FIG. 7. Afterinsertion, the wheel 330 and track 368 may couple such that rotationalforce provided by motor 366 causes wheel 330 to rotate via the track368. In one example, the rotational distance may be divided into apredetermined number of evenly spaced intervals (e.g., 20 intervals)corresponding to respective cassette usages. After the final intervalhas turned, the following interval (e.g., beginning of the 21^(st)interval) will cause the protrusion 390 to come into contact withstructure 364, and thus preventing further rotation. In one illustrativeembodiment, the blocking of rotation in the wheel may cause the cassettesystem (e.g., 200) to generate a signal indicating that the cassette isnot valid. In another illustrative embodiment, protrusion 390 andstructure 364 may be manufactured from a conductive material such thatphysical contact may cause an electronic circuit to close, indicatingthe cassette should not be used further.

FIG. 7A shows a combined view of cassette 250 inserted in console 365 ofa cassette system (e.g., 200). Here, the example shows a new cassettewith wheel 330 having protrusion 390 positioned at a “start” positionnext to structure 364 of console track 368. As explained above, aftereach user, wheel 330 may rotate, causing protrusion 390 to rotate in aclockwise direction until it is blocked from the other side of structure364, indicating that the cassette 250 may no longer be used. In otherillustrative embodiments, the usage tracking system may include twogears, one in the console 365 and one in the cassette 250, that interactwith each other to rotate or advance a wheel with each use of thecassette 250 until the wheel is prevented from any further rotation dueto the maximum number of uses being reached. Other similar embodimentsof a tracking mechanism may be within the scope of the presentdisclosure.

In another embodiment, track 368 may have a predefined shaped, e.g., acrescent, c-shape, u-shape, or incomplete circle or square, that permitsprotrusion 390 to following from a first point indicating the first useto a second point indicating the last use, wherein there is a defineddistance between the first point and the second point permitting adefined number of uses of cassette 250 by permitting movement ofprotrusion 390 between the first point and the second point. Thedistance between the first point and the second point can be defined toallow varying number of interval distances corresponding to the numberof permitted uses per cassette. As wheel 330 rotates in cassette 250,protrusion 390 rotates and moves along track 368 and will continue tofunction until it reaches the second point of track 368.

FIG. 7B shows another illustrative embodiment including wheel 702configured to rotate axially around shaft 714 in the direction of thedotted arrow shown in FIG. 7B. In this example, wheel 702 houses aplurality of latches 706 that extend along the circumference of wheel702, where the latches 706 are statically fixed. In one embodiment, eachof the latches 706 may be shaped to facilitate or assist passage acrossresilient protrusion 710. In the example of FIG. 7B, the latches 706 andresilient protrusion 710 are configured with an angled face that may beangled in a complementary manner to provide reduced surface resistanceas each latch (706) passes across resilient protrusion 710. It should beunderstood by those skilled in the art that any suitable configuration(e.g., multi-angled, rounded, etc.) may be used for latch 706 andresilient protrusion 710 faces to achieve this effect.

As each latch 706 passes across resilient protrusion 710 duringrotation, a portion or face of latch 706 comes in contact with resilientprotrusion 710, which forces resilient protrusion 710 to retract toallow latch 706 to pass across. Once each latch 706 passes, theresilient protrusion 710 may spring back to accept the next oncominglatch 706. The retraction and spring-back is illustrated as the dottedarrow shown in FIG. 7B. In the example of FIG. 7B, the resilientprotrusion 710 is shown as a part of console 708. However, it should beappreciated by those skilled in the art that resilient portion 710 maybe configured in any suitable area of a cassette system (e.g., 200), andmay also be independently mounted.

As explained elsewhere herein, each latch 706 may be configured torepresent a single cassette usage. After each use, wheel 702 may bemechanically and/or electromechanically advanced rotationally untillatch 706 passes across resilient protrusion 710, causing it to retractand spring back to its original position. Resilient protrusion 710 maybe configured with a spring, coil, band, or any other suitable materialknown in the art to provide resilience to resilient protrusion 710.Under an illustrative embodiment, upon a final usage, stop latch 704 maybe configured to have a shape that obstructs passage of stop latch 704past resilient protrusion 710. In the example of FIG. 7B, stop latch 704may be configured to extend further than any of latches 706, and/or beconfigured with a shape (e.g., square) that increases surface resistanceand/or applies lateral force that exceeds the resilience of resilientprotrusion 710, thus preventing the resilient protrusion 710 fromretracting and not allowing the stop latch 704 to pass.

FIG. 7C shows an illustrative embodiment that is similar to that of FIG.7B, except that, instead of having fixed latches and a resilientprotrusion, each of the latches are resilient, and the protrusion isfixed. In this example, wheel 722 includes a resilient latch housing 726that holds a plurality of resilient latches 728, and rotates axiallyaround shaft 724. In one illustrative embodiment, as each resilientlatch 728 rotates and comes in contact with fixed protrusion 732, theforce of the contact causes resilient latch 728 to retract to allowlatch 728 to pass. In one illustrative embodiment, resilient latch 728may spring back after passing. In another illustrative embodiment,resilient latch 728 may include a lock 734 that locks latch 728 into aretracted position within housing 724. Such a configuration may beadvantageous to allow visual inspection to determine the number of uses,and/or the number of uses remaining. While not shown in FIG. 7C, anindividual or universal release mechanism may be provided within latchhousing 726 to release locked resilient latches 728 back to theirextended (non-compressed) positions. This configuration would beadvantageous in circumstances where a user would re-use wheels 722 afterall of the uses have been registered for a particular cassette system.

Similar to the embodiment of FIG. 7B, each resilient latch 728 may beconfigured to represent a single cassette usage. After each use, wheel722 may be mechanically and/or electromechanically advanced rotationallyuntil each resilient latch 728 passes across fixed protrusion 732,causing each to retract. Resilient latches 728 may each be configuredwith a spring, coil, band, or any other suitable material known in theart to provide resilience to each latch. Under an illustrativeembodiment, upon a final usage, a non-resilient stop-latch 730 may beconfigured as a fixed latch that stops further rotation of wheel 722when coming in contact with protrusion 732 to indicate a final use for acassette system. In an illustrative embodiment, stop latch 730 may alsobe configured to extend further than resilient latches 728 and/or have ashape that increases surface resistance to that obstruct passage of stoplatch 730 past protrusion 732.

FIG. 7D shows a further embodiment where a disk 750 inside the cassetteis coupled to shaft 752 inside the console to allow disk 750 to rotatemechanically and/or electromechanically after each cassette systemusage. In this example, disk 750 is configured with a plurality ofinsertion pockets 756 shaped and extending radially from thecircumference of disk 750 to receive similarly-shaped implement 754. Byutilizing sensors (e.g., sensor 304), the system can determine when theimplement is extended into each insertion pocket 756. In an illustrativeembodiment, insertion pockets 756 may be configured with rounded orbeveled edges to allow the implement 754 to slide with reducedfriction/resistance from one insertion pocket to the next.

Similar to the embodiments of FIG. 7B and 7C, each insertion pocket 756may be configured to represent a single cassette usage. After each use,disk 750 may be mechanically and/or electromechanically advancedrotationally such that implement 754 inserts and releases from eachsuccessive insertion pocket 756. In an illustrative embodiment,implement 754 may be configured with a spring, coil, band, etc. toensure a more secure insertion in to each insertion pocket 756. Upon afinal usage, a stop pocket 758, having a different shape (or not havinga pocket in the stop position) from insertion pockets (756) and/orconfigured to obstruct implement 754, prevents implement 754 from fullyinserting, indicating a final use for a cassette system and preventingfurther use of the cassette.

It should be understood by those skilled in the art that the presentdisclosure contemplates a plurality of modifications to the illustrativeembodiments provided herein. For example, stop pocket 758 may beconfigured to have the same shape as insertion pockets 756, but having adifferent depth. For example, stop pocket 758 may be configured to havea deeper depth, which, in effect, would prevent the implement 754 fromproceeding further. In another example, the latches, protrusions,pockets and implements may be manufactured from (or coated with) anelectrically conductive material. Utilizing sensor circuitry (e.g.,304-305), a cassette system may determine a use from each time contactis made. In one example, latches (706, 728) may be configured to rotateand make contact with a respective protrusion (710, 732). The cassettesystem may be configured to allow further operation only when suchelectrical contact is detected. By configuring stop latches (704, 730)to be made from non-conductive material, a cassette system would stopoperation, since no electrical contact would be detected. Similarly,insertion pockets (756) could include electrical contacts to detectcoupling with a suitably conductive implement 754. A stop pocket (758)may be configured without an electric contact to indicate a final use.Of course, one skilled in the art would recognize that a reverseconfiguration is contemplated as well, i.e., allowing the cassettesystem to operate when no electrical contact is detected, and stoppinguse when contact is detected (e.g., providing an electrical contact onlyin the stop latch/pocket).

Turning to FIG. 8, another exemplary embodiment of a usage trackingsystem 300 is provided including a passive RFID chip 380 that is coupledto the cassette. The RFID chip 380 can indicate and track the number ofuses of a particular cassette, and relay that information to an RFIDreader 382 located, for example, on the console 115. The RFID chip 380may also identify the maximum number of uses for a cassette. In suchembodiments, multiple phacoemulsification systems in a network may belinked via WiFi or some other connections so that if the same cassetteis used on one machine and transferred to another it can be detected andthe use counted. In such embodiments, there may be global networkcontrol of cassette usage as well.

FIG. 9 shows an illustrative embodiment of a wheel arrangement, suitablefor use in the embodiments of FIGS. 7-7A, or other embodiments of thepresent disclosure. In this example, wheel 330 includes an open track369 that may travel along a circumpherential area of wheel 330 as shownin the figure. The open track 369 may be configured to receive aprotrusion or structure (e.g., 364) such that the protrusion would bepositioned at point 1 (369A) after initial insertion of a cassette(e.g., 250) into a console (e.g., 365). As the wheel 330 is rotated, theinserted structure would follow the path defined by open track 369 untilit reaches point 2 (369B), at which point the structure would be blockedfrom further rotation (similar to the blocking provided by protrusion390 and structure 364 configuration described above in connection withFIGS. 7-7A). It should be understood that wheel 330 of FIG. 9 may bearranged from either a cassette 250 side or a console 365 side. Thus, ifcassette 250 was configured with wheel 330 of FIG. 9, the structure 364would be configured to be insertably coupled to open track 369.Conversely, if console 365 was configured with wheel 330 of FIG. 9, theprotrusion 390 would be configured to be insertably coupled to opentrack 369.

Those of ordinary skill in the art may recognize that many modificationsand variations of the herein disclosed systems and methods may beimplemented without departing from the spirit or scope of the invention.Thus, it is intended that the present invention covers suchmodifications and variations provided they come within the scope theappended claims and their equivalents.

What is claimed is:
 1. A reusable cassette sensing apparatus, configuredto be part of a surgical device, comprising: a film configured toindicate a maximum number of uses of the surgical device; a trackingsystem comprising an implement, at least one sensor and a processor,wherein the implement is configured to engage with the film, and whereinthe at least one sensor is configured to sense the maximum number ofuses from the film, and, prior to a use of the surgical device, theprocessor is configured to determine if the maximum number of uses hasbeen reached based at least on a number of engagements of the implementwith the film.
 2. The reusable cassette sensing apparatus of claim 1,wherein the processor is configured to provide a signal indicating themaximum number of uses has been reached.
 3. The reusable cassettesensing apparatus of claim 2, wherein the signal comprises at least oneof a warning signal, a disable signal and an eject signal.
 4. Thereusable cassette sensing apparatus of claim 1, wherein the at least onesensor is configured to sense the maximum number of uses from the filmvia at least one of optical and electrical scanning of the film.
 5. Thereusable cassette sensing apparatus of claim 1, wherein the at least onesensor is configured to sense the maximum number of uses from the filmvia a film identifier affixed to the film.
 6. The reusable cassettesensing apparatus of claim 5, wherein the film identifier comprises oneof a bar code, a QR code and a RFID tag.
 7. The reusable cassettesensing apparatus of claim 1, wherein the implement comprises one of apunch, cutter, ink ejection, and light emitter.
 8. A method for trackingusage of a reusable cassette, configured to be part of a surgicaldevice, comprising: sensing, prior to use of the surgical device, amaximum number of uses from a film configured to indicate a maximumnumber of uses of the reusable cassette; provided that the maximumnumber of uses has not been reached, activating an implement to engagewith the film; and based at least in part on the implement's engagementwith the film, determining a remaining number of usage for the reusablecassette.
 9. The method of claim 8, further comprising the step ofproviding a signal indicating the maximum number of uses has beenreached based on the sensing.
 10. The method of claim 9, wherein thesignal comprises at least one of a warning signal, a disable signal andan eject signal.
 11. The method of claim 8, wherein the sensingcomprises sensing the maximum number of uses from the film via at leastone of optical scanning and electrical sensing of the film
 12. Themethod of claim 8, wherein the sensing the maximum number of uses fromthe film comprises sensing via a film identifier affixed to the film.13. The method of claim 12, wherein the film identifier comprises one ofa bar code, a QR code and a RFID tag.
 14. The method of claim 8, whereinthe implement comprises one of a punch, cutter, ink ejection, and lightemitter.
 15. An apparatus, configured to be part of a surgical device,comprising: a reusable cassette system, the reusable cassette systemhaving a predetermined maximum number of uses; a usage tracking systemconfigured to track a maximum number of uses of the reusable cassette,the usage tracking system including means for determining the number ofuses remaining on the reusable cassette and means for providing a signalindicating the maximum number of uses has been reached; and acommunications system that permits transmission of data from the usagetracking system to an operator of the surgical device.
 16. The apparatusof claim 15, wherein the usage tracking system comprises an implementand a film, the film configured to indicate the number of instances thatthe reusable cassette has been used.
 17. The apparatus of claim 16,wherein the usage tracking system further comprises, at least one sensorand a processor connected to the sensor.
 18. The apparatus of claim 16,wherein the implement comprises one of a punch, cutter, ink ejection,and light emitter that interacts with the film to modify the physicalcharacteristics of the film when the reusable cassette system has beenused
 19. The apparatus of claim 17, wherein the at least one sensor isconfigured to sense the number of instances that the reusable cassettehas been used from the film.
 20. The apparatus of claim 19, wherein thefilm is further configured to indicate the maximum number of uses forthe reusable cassette.
 21. The apparatus of claim 20, wherein the atleast one sensor is also configured to sense the maximum number of usesfrom the film.
 22. The apparatus of claim 21, wherein, prior to a use ofthe surgical device, the processor is configured to determine if themaximum number of uses has been reached based on the maximum number ofuse data and the number of instances of use data sensed by the sensor.23. The apparatus of claim 17, wherein the processor is configured toprovide a signal to the communications system indicating the maximumnumber of uses has been reached.
 24. The apparatus of claim 23, whereinthe signal comprises at least one of a warning signal, a disable signaland an eject signal.
 25. The apparatus of claim 21, wherein the at leastone sensor is configured to sense the maximum number of uses from thefilm via at least one of optical and electrical scanning of the film.26. The apparatus of claim 15, wherein the usage tracking systemcomprises a rotatable wheel and an implement, the rotatable reader isconfigured to track the number of instances that the reusable cassettehas been used and the implement is configured to engage with the wheelto determine the number of instances that the reusable cassette has beenused.
 27. The apparatus of claim 26, wherein the wheel is divided intopredetermined segments that correspond to the maximum number of uses ofthe reusable cassette, and wherein the wheel rotates with each use ofthe reusable cassette such that amount of the rotation corresponds tothe predetermined segments.
 28. The apparatus of claim 27, wherein thepredetermined segment related to the last use includes a dark or blackcolor in the segment, and the remaining predetermined segments include alight or white color in the segment.
 29. The apparatus of claim 28,wherein the implement is a reader, and the reader is positioned in astationary position with respect to the wheel and can read thepredetermined segments as the wheel rotates.
 30. The apparatus of claim29, wherein the reader includes a sensor that can determined whether apredetermined segment includes a dark or black color or a light or whitecolor in the segment.
 31. The apparatus of claim 26, wherein the usagetracking system further comprises at least one processor, the processorconnected to the reader, the processor configured to provide a signalindicating the maximum number of uses of the reusable cassette has beenreached.
 32. The apparatus of claim 27, wherein the implement is apinion and wherein the wheel includes an edge with outwardly extendingprotrusions that correspond to each of the predetermined segments, thepinion being configured to be biased against the edge of the wheel andtrack the number of uses of the reusable cassette by engagement with theoutwardly extending protrusions.
 33. The apparatus of claim 32, whereinthe wheel is only configured to rotate in one direction, clockwise orcounterclockwise, and cannot rotate in the opposite direction.
 34. Theapparatus of claim 26, wherein the implement is a latch that can matingengage with a portion of the wheel to rotate the wheel, the latch movingalong a latch-movement path to rotate the wheel with each use of thereusable cassette.
 35. The apparatus of claim 34, wherein the usagetracking system further includes a structure that is positioned to bestationary when the wheel rotates, the structure blocking movement ofthe latch along the latch-movement path when the maximum number of usesof the reusable cassette has been reached.
 36. The apparatus of claim34, wherein the latch moves along the latch-movement path throughconnection with a moveable track.
 37. The apparatus of claim 34, wherethe usage tracking system comprises two or more latches that engage witha portion of the wheel to rotate the wheel.
 38. The apparatus of claim37, wherein the wheel further includes a blocking mechanism that rotateswith the wheel.
 39. The apparatus of claim 38, wherein the usagetracking system further includes a structure that is positioned to bestationary when the wheel rotates, the blocking mechanism positioned toabut against the structure when the maximum number of uses of thereusable cassette has been reached.
 40. The apparatus of claim 15,wherein the usage tracking system includes an RFID chip coupled to thereusable cassette and an RFID reader that can receive informationregarding the number of uses of the reusable cassette from the RFIDchip.
 41. The apparatus of claim 26, wherein the wheel comprises anon-contiguous groove engagable by the implement wherein at least oneterminus end of the groove is indicative of the maximum number of usesof the reusable cassette.
 42. A cassette apparatus, configured to bepart of a surgical device, comprising: a disk comprising a plurality ofinsertion pockets indicative of a maximum number of uses of a surgicalcassette; and an implement communicatively coupled to at least onesensor and a processor, wherein the implement is configured to engagewith ones of the plurality of insertion pockets, wherein the at leastone sensor is configured to sense the maximum number of uses from theinsertion of the implement into ones of the plurality of insertionpockets, and, prior to a use of the surgical device, the processor isconfigured to determine if the maximum number of uses has been reachedbased at least on a number of engagements of the implement with theplurality of insertion pockets.